- Common frustrations with sponsors
- What good collaboration looks like
- How sponsors can make studies easier to run
- Practical challenges that improve site performance
- How regulators are using real-world evidence
- What evidence sponsors should start generating now
- Regulatory expectations over the next 3-5 years
- Preparing for future submissions
- Introducing first-in-human therapies safely in small patient populations
- Balancing safety, efficacy and speed throughout development
- Using adaptive clinical trial designs where appropriate to accelerate development without compromising quality
- Working effectively with orphan drug pathways and regulators
- Practical lessons from rare disease clinical development programmes that delegates can apply within their own organisations
- Identifying high-risk protocol elements before finalisation
- Using site and investigator feedback before study start-up
- Balancing scientific ambition with operational feasibility
- Reducing rework through better cross-functional review
